Center for Prospective Clinical Trials, Department of Surgery, The Children's Mercy Hospital, Kansas City, MO 64108, USA.
Ann Surg. 2012 Oct;256(4):581-5. doi: 10.1097/SLA.0b013e31826a91e5.
The efficacy of irrigating the peritoneal cavity during appendectomy for perforated appendicitis has been debated extensively. To date, prospective comparative data are lacking. Therefore, we conducted a prospective, randomized trial comparing peritoneal irrigation to suction alone during laparoscopic appendectomy in children.
Children younger than 18 years with perforated appendicitis were randomized to peritoneal irrigation with a minimum of 500 mL normal saline, or suction only during laparoscopic appendectomy. Perforation was defined as a hole in the appendix or fecalith in the abdomen. The primary outcome variable was postoperative abscess. Using a power of 0.8 and alpha of 0.05, a sample size of 220 patients was calculated. A battery-powered laparoscopic suction/irrigator was used in all cases. Pre- and postoperative management was controlled. Data were analyzed on an intention-to-treat basis.
A total of 220 patients were enrolled between December 2008 and July 2011. There were no differences in patient characteristics at presentation. There was no difference in abscess rate, which was 19.1% with suction only and 18.3% with irrigation (P = 1.0). Duration of hospitalization was 5.5 ± 3.0 with suction only and 5.4 ± 2.7 days with group (P = 0.93). Mean hospital charges was $48.1K in both groups (P = 0.97). Mean operative time was 38.7 ± 14.9 minutes with suction only and 42.8 ± 16.7 minutes with irrigation (P = 0.056). Irrigation was felt to be necessary in one case (0.9%) randomized to suction only. In the patients who developed an abscess, there was no difference in duration of hospitalization, days of intravenous antibiotics, duration of home health care, or abscess-related charges.
There is no advantage to irrigation of the peritoneal cavity over suction alone during laparoscopic appendectomy for perforated appendicitis. The study was registered with clinicaltrials.gov at the inception of enrollment (NCT00981136).
在阑尾穿孔时进行腹腔冲洗的疗效一直存在广泛争议。迄今为止，尚无前瞻性对照数据。因此，我们进行了一项前瞻性、随机试验，比较了儿童腹腔镜阑尾切除术中腹腔冲洗与单纯抽吸的效果。
将年龄小于 18 岁的阑尾穿孔患者随机分为腹腔冲洗组（用至少 500ml 生理盐水冲洗）和单纯抽吸组（腹腔镜阑尾切除术中单纯抽吸）。穿孔定义为阑尾有孔或腹部有粪石。主要观察指标为术后脓肿。采用 0.8 的功效和 0.05 的α值，计算出需要 220 例患者的样本量。所有患者均采用电池供电的腹腔镜抽吸/冲洗器。所有患者均采用术前和术后相同的处理方式。数据采用意向治疗进行分析。
2008 年 12 月至 2011 年 7 月期间共纳入 220 例患者。两组患者在就诊时的特征无差异。单纯抽吸组和冲洗组的脓肿发生率分别为 19.1%和 18.3%（P=1.0），无差异。单纯抽吸组和冲洗组的住院时间分别为 5.5±3.0 天和 5.4±2.7 天（P=0.93）。两组的平均住院费用均为 48.1K 美元（P=0.97）。单纯抽吸组和冲洗组的平均手术时间分别为 38.7±14.9 分钟和 42.8±16.7 分钟（P=0.056）。在随机分配至单纯抽吸组的患者中，有 1 例（0.9%）认为有必要冲洗腹腔。在发生脓肿的患者中，住院时间、静脉使用抗生素天数、家庭保健时间以及脓肿相关费用均无差异。
在腹腔镜阑尾切除治疗穿孔性阑尾炎时，腹腔冲洗与单纯抽吸相比没有优势。本研究在入组时在 clinicaltrials.gov 上进行了注册（NCT00981136）。
